Treatment of Nevus Flammeus With Alexandrite Laser

NCT ID: NCT01968681

Last Updated: 2015-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-12-31

Brief Summary

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Nevus flammeus is a congenital vascular malformation. Nevus flammeus is traditionally treated with pulsed dye lasers (PDL); however, around 20 percent of patients are poor responders and do not get satisfactory results from pulsed dye laser treatments.

Small studies with alexandrite lasers indicate that this may be an alternative treatment for individuals with nevus flammeus. This study assesses the clinical effect and side effects of alexandrite laser treatment for nevus flammeus using different treatment settings.

Detailed Description

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Conditions

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Nevus Flammeus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Alexandrite laser treatment

Group Type EXPERIMENTAL

Alexandrite laser

Intervention Type PROCEDURE

3 different alexandrite laser settings are used in respectively 3 different treatment areas and compared with a non-treated control area.

Interventions

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Alexandrite laser

3 different alexandrite laser settings are used in respectively 3 different treatment areas and compared with a non-treated control area.

Intervention Type PROCEDURE

Other Intervention Names

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Candela Gentle Max

Eligibility Criteria

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Inclusion Criteria

* 10 or more years of age
* Fitzpatrick Skin Type I-III
* Previously untreated or pulsed dye laser-insufficiently treated nevus flammeus
* Nevus flammeus size minimum 8 x 2 centimeter within one anatomical region
* Written and oral informed consent

Exclusion Criteria

* Known light sensibility toward visible light
* Tendency to develop hypertrophic scars or keloids
* Fitzpatrick Skin Type IV-VI
* Individuals, that are obviously pigmented due to recent sun exposure or sun beds
* Treatment with systemic retinoids within 6 months
* Pregnancy and lactation
* Unwillingness to complete protocol
Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Merete Haedersdal

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Merete Haedersdal, Professor

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital

Locations

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Bispebjerg Hospital

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-4-2013-066

Identifier Type: -

Identifier Source: org_study_id

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